Quality Assurance and Regulatory Affairs Specialist 

Senior Quality Assurance and Regulatory Affairs Specialist

We are searching for an experienced Specialist who considers Quality Assurance and Regulatory guidelines a “must have” for all product development projects; someone who enjoys focusing on the daily maintenance and implementation of a Quality Management System (QMS) and contributing to the ongoing improvement of processes in engineering development and manufacturing; an individual who is looking for a special company where creativity, innovation and most-importantly, quality is embraced and celebrated.

The Senior Quality Assurance and Regulatory Affairs Specialist will have the opportunity to deliver customized QMS-in-a-box solutions for our customers, participate in audits, write or review Standard Operating Procedures (SOP) and will manage and drive solutions for Non-Conformance reports, customer complaints and vendor corrective actions. The Specialist will support and manage regulatory submissions for medical devices, review change control documents, and support the project management team throughout each product’s life cycle. It will be critical to effectively communicate with and collaborate with this multi-disciplinary team of senior designers, engineers and physicists.

ABOUT STARFISH MEDICAL

StarFish teams work in energizing, purpose-designed facilities with some of the best medical device design strategists, designers and engineers in North America to help direct, create and deliver exciting product experiences for varied device markets and customers. Expand your career and industry experience while fostering relationships with our top-tier medical technology clients, all while working on cutting edge projects that range from tactical EMS products, surgical tools and consumer diagnostic devices through to high volume disposables, complex IVD systems, imaging technologies and lab equipment.

You would be working in beautiful Victoria, BC or Toronto, On where visitors are immediately met with a smile. The working environment is filled with both a sense of driven scientific and engineering excellence, and also genuine employee engagement and transparency that is truly meaningful.

In our surveys, our employees rated: peers and culture, interesting and meaningful work, and working conditions (flexibility, environment) as the top reasons they most enjoyed working at StarFish.

If this is the type of collegial and supportive environment you strive to be a part of, and you love making a positive impact to improve the manufacturing processes and product quality, while working directly with our clients and product development teams, then we encourage you to read on!

OUR PERFECT CANDIDATE

Reporting to the QA/RA Director, you will bring a minimum of 10 years of work experience in quality assurance and/or regulatory affairs in a Good Manufacturing Practices (GMP) regulated environment, preferably medical devices. Ideally, you will have a Bachelor Degree in the sciences or engineering, and experience in a high-tech industry; management experience is a plus. You have an in-depth understanding of QMS and ISO standards with solid experience in auditing, interpreting and applying regulations and compliance concepts. You understand that collaborative, cross functional teams are the most effective, and your communication skills successfully bring these diverse groups together to spawn creative, open-minded and out-of-the-box thinking.

As a member of the Quality Assurance/Regulatory Affairs team, you will provide quality assurance and regulatory support to medical devices product development and manufacturing departments in either Victoria or Toronto office. Duties may include, but are not limited to the list below.

 JOB RESPONSIBILITIES

  • Interact and communicate effectively with all departments of Starfish Medical, ViVitro Labs Inc., the customer base, regulatory bodies and any related contracting services
  • Provide guidance and input on QA and RA issues for PD and Manufacturing projects; support improvements as appropriate
  • Manage and drive solutions to Non-Conformance Reports (NCRs), customer complaints and vendor corrective actions
  • Assist Project Managers with documentation required for regulatory submissions:
  • Review design inputs for regulatory compliance
  • Review design outputs for regulatory compliance (60601, 14971, RoHS, etc)
  • Deliver customized QMS-in-a-box solutions against customer contracts
  • Review and/or write SOPs (Standard Operating Procedures) and Work Instructions
  • Participate in internal audits of the Quality Management System, prepares audit reports and follow up on non-conformances
  • Review of internal and external change control documents related to the manufacturing process
  • Identify manufacturing process issues based on product testing results
  • Monitor the effectiveness of product Quality testing including:
    • Documentation of final test results
    • Review of Device History Records (DHRs) and product release
    • Provide input on decisions to approve/reject (Engineering Change Requests) ECRs
  • Follow up on CAPA, (Corrective Actions Preventive Actions) NCRs (Non Conformance Report) and ECRs (Engineering Change Requests); participate in root cause analysis
  • Work closely with personnel to resolve all issues resulting from review (document corrections, deviations, and clarifications)
  • Provide data for preparation of monthly Quality Assurance reports including quality issues by product, metrics and summary of any quality problems
  • Periodically assist with preparation of Management reports
  • Participate in Project Kick-off meetings, Engineering Design Reviews, Gate Reviews, Risk Assessment and Analysis sessions as required
  • Review DHF, DMR and DHRs including verification and validation documents during product development and manufacturing
  • Participate in developing and training on quality and regulatory courses as needed
  • Communicate with internal groups at Starfish Medical and clients to resolve quality issues to support batch release and disposition
  • Handles regulatory agency and client inspections as required
  • Provides regulatory support for new products and supports or handles regulatory submissions
  • Perform other duties as assigned

QUALIFICATIONS

  • Bachelor degree preferably in technical, science or engineering field with a minimum of 10 years of work experience in quality assurance and/or regulatory affairs role in GMP (Good Manufacturing Practices) regulated environment, preferably medical devices or equivalent combination of education and experience.
  • Management experience in high-tech industry desirable
  • Lead ISO 13485 Auditor, ASQ, SQA or RAPs RAC certification desirable

JOB REQUIREMENTS

  • In depth understanding of a Quality Management System, and requirements of ISO 13485, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820 Quality System Regulations, and EU Directive for medical devices 93/42/EEC
  • Experience with 510 (K), Health Canada Medical device license and CE Mark requirements
  • Strong auditing skills with experience of creating and driving improvements based on findings
  • Thorough understanding of quality assurance concepts and practices
  • Detailed oriented
  • Ability to interpret and apply regulations and compliance concepts
  • Excellent communication skills (written and verbal)
  • Demonstrates proactive thinking and actions
  • Ability to read and respond to audiences appropriately
  • Familiar with basic test equipment and basic statistical analysis
  • Computer literate (MS Office)
  • Ability to work with minimal supervision

ADDITIONAL REQUIREMENTS

  • Some travel and light lifting may be required.

 

HOW TO APPLY

Qualified applicants are encouraged to apply in confidence to careers@tallsky.ca with a resume and a covering letter that indicates the position you are applying for, lists your salary expectations, and clearly indicates how your education and experience meet each of the requirements of this position. Salary will be commensurate with skills and experience, and a benefits and profit sharing package are included.

We thank everyone who applies, but only those candidates selected for an interview will be contacted.  No phone calls please.